Label: TRIPLE ANTIBIOTIC 01- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 82953-013-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2024

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  • Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin Zinc 400U/g

    Neomycin Sulfate (3.5mg Neomycin)

    Polymyxin B Sulfate 5000U/g

  • Purpose

    Antibiotics

  • Uses

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only.

    Do not use.

    • in or near the eyes
    • for diaper rash; ask a doctor
  • ASK DOCTOR

    Ask a doctor before use if you are using any other hydrocortisone product

  • STOP USE

    Stop use and ask doctor if

    • condition worsens or if symptoms persist for more than 7 days
    • symptoms last more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If ingested, contact Poison Control Center right away.

  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years do not use; ask a doctor
  • STORAGE AND HANDLING

    Other information

    protect from Excessive Heat (40 oC/ 104 oF.)

  • Inactive Ingredients

    Water, Cetearyl Alcohol, Glycerin, Glycerin, Ceteareth-20, Isopropyl Myristate, Disodium EDTA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

  • PRINCIPAL DISPLAY PANEL

    82953-013

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  01
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-013-010.9 g in 1 BAG; Type 0: Not a Combination Product01/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/04/2024
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-013)
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